{"id":4228,"date":"2023-06-29T17:01:44","date_gmt":"2023-06-29T15:01:44","guid":{"rendered":"https:\/\/www.riskmanager.net\/?page_id=4228"},"modified":"2023-06-29T17:01:44","modified_gmt":"2023-06-29T15:01:44","slug":"medical-device-regulation-clinical-evaluation","status":"publish","type":"page","link":"https:\/\/www.riskmanager.net\/en\/modules-features\/modules\/medical-device-regulation-clinical-evaluation\/","title":{"rendered":"Medical Device Regulation Clinical Evaluation"},"content":{"rendered":"\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_section-0483bb3984f0ffc576a75cb1817e5781\">\n.avia-section.av-av_section-0483bb3984f0ffc576a75cb1817e5781{\nbackground-repeat:no-repeat;\nbackground-image:url(https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/shutterstock_21844750-1030x687.jpg);\nbackground-position:50% 100%;\nbackground-attachment:fixed;\n}\n.avia-section.av-av_section-0483bb3984f0ffc576a75cb1817e5781 .av-section-color-overlay{\nopacity:0.8;\nbackground-color:#93c9c5;\n}\n<\/style>\n<div id='av_section_1'  class='avia-section av-av_section-0483bb3984f0ffc576a75cb1817e5781 main_color avia-section-default avia-no-shadow  avia-builder-el-0  el_before_av_section  avia-builder-el-first  avia-full-stretch avia-bg-style-fixed av-section-color-overlay-active av-minimum-height av-minimum-height-custom av-height-custom  container_wrap fullsize'  data-section-bg-repeat='stretch' data-av_minimum_height_px='500'><div class=\"av-section-color-overlay-wrap\"><div class=\"av-section-color-overlay\"><\/div><div class='container av-section-cont-open' style='height:500px'><main  role=\"main\" itemprop=\"mainContentOfPage\"  class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-4228'><div class='entry-content-wrapper clearfix'>\n<\/div><\/div><\/main><!-- close content main element --><\/div><\/div><\/div><div id='av_section_2'  class='avia-section av-av_section-383c550227c0c1d9007994a050b6fccc alternate_color avia-section-default avia-no-shadow  avia-builder-el-1  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-4228'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-2568556825e4047e37e416ce554f6d5e\">\n#top .av-special-heading.av-av_heading-2568556825e4047e37e416ce554f6d5e{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-2568556825e4047e37e416ce554f6d5e .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-2568556825e4047e37e416ce554f6d5e .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-2568556825e4047e37e416ce554f6d5e av-special-heading-h1 blockquote modern-quote modern-centered  avia-builder-el-2  el_before_av_textblock  avia-builder-el-first '><div class='av-subheading av-subheading_above'><p>Meeting the requirements with the BAYOOSOFT RISK Manager<\/p>\n<\/div><h1 class='av-special-heading-tag '  itemprop=\"headline\"  >Clinical evaluation of medical devices according to MDR<\/h1><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>According to the Medical Device Directive MDR 2017\/745 and MEDDEV 2.7.1, manufacturers are obliged to conduct a clinical evaluation over the entire life cycle of a medical device. This serves the following objectives:<\/p>\n<\/div><\/section>\n<div  class='avia-icon-list-container av-av_iconlist-b9622264be8b33ecf932b804b1272287  avia-builder-el-4  el_after_av_textblock  el_before_av_icon_box '><ul class='avia-icon-list avia_animate_when_almost_visible avia-icon-list-left av-iconlist-big av-av_iconlist-b9622264be8b33ecf932b804b1272287 avia-iconlist-animate'>\n<li><div class='iconlist_icon av-av_iconlist_item-26d1c6bc13fb7cd0c87e515d36133688 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Demonstration of sufficient clinical benefit of the device\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Demonstration of sufficient clinical benefit of the device<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-8eaccf952a2d56be98fa3129ae170d02 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Ensuring that no unexpected or unacceptable side effects occur\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Ensuring that no unexpected or unacceptable side effects occur<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<li><div class='iconlist_icon av-av_iconlist_item-07b9e33e69104dd3047838c4b2c41084 avia-font-entypo-fontello'><span class='iconlist-char' aria-hidden='true' data-av_icon='\ue812' data-av_iconfont='entypo-fontello'><\/span><\/div><article class=\"article-icon-entry av-iconlist-empty\"  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconlist_content_wrap\"><header class=\"entry-content-header\" aria-label=\"Icon: Evidence of the justifiability of the risk-benefit balance\"><h4 class='av_iconlist_title iconlist_title  '  itemprop=\"headline\" >Evidence of the justifiability of the risk-benefit balance<\/h4><\/header><div class='iconlist_content '  itemprop=\"text\" ><\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article><div class=\"iconlist-timeline\"><\/div><\/li>\n<\/ul><\/div>\n<article  class='iconbox iconbox_top av-av_icon_box-db14d686fb6aaee893bd84c2c5c4eb8d  avia-builder-el-5  el_after_av_iconlist  avia-builder-el-last  main_color'  itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class=\"iconbox_content\"><header class=\"entry-content-header\" aria-label=\"Icon: Sources of clinical evaluation\"><div class=\"iconbox_icon heading-color\" aria-hidden='true' data-av_icon='\ue81e' data-av_iconfont='entypo-fontello'><\/div><h3 class='iconbox_content_title '  itemprop=\"headline\" >Sources of clinical evaluation<\/h3><\/header><div class='iconbox_content_container '  itemprop=\"text\" ><p>According to MDR Article 2(48), clinical data refers to information obtained in the course of use concerning the safety and performance of the device. Such data may be generated in a clinical trial or taken from the specialist literature. This includes, inter alia, clinical trials already conducted or other studies published in the specialist literature concerning a device that has been proven to be similar.<\/p>\n<\/div><\/div><footer class=\"entry-footer\"><\/footer><\/article>\n\n<\/div><\/div><\/div><!-- close content main div --><\/div><\/div><div id='av_section_3'  class='avia-section av-av_section-ae7d79a49e3157f3b27e76ea004b5c76 main_color avia-section-default avia-no-shadow  avia-builder-el-6  el_after_av_section  el_before_av_section  avia-bg-style-scroll container_wrap fullsize'  ><div class='container av-section-cont-open' ><div class='template-page content  av-content-full alpha units'><div class='post-entry post-entry-type-page post-entry-4228'><div class='entry-content-wrapper clearfix'>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_heading-f418fd7f2264eae6dfc2fe182b2fde93\">\n#top .av-special-heading.av-av_heading-f418fd7f2264eae6dfc2fe182b2fde93{\npadding-bottom:10px;\n}\nbody .av-special-heading.av-av_heading-f418fd7f2264eae6dfc2fe182b2fde93 .av-special-heading-tag .heading-char{\nfont-size:25px;\n}\n.av-special-heading.av-av_heading-f418fd7f2264eae6dfc2fe182b2fde93 .av-subheading{\nfont-size:15px;\n}\n<\/style>\n<div  class='av-special-heading av-av_heading-f418fd7f2264eae6dfc2fe182b2fde93 av-special-heading-h2  avia-builder-el-7  el_before_av_image  avia-builder-el-first '><h2 class='av-special-heading-tag '  itemprop=\"headline\"  >Clinical evaluation of medical devices in the Risk Manager<\/h2><div class=\"special-heading-border\"><div class=\"special-heading-inner-border\"><\/div><\/div><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-a2da42523847e50c79f99ab133ffce66\">\n.avia-image-container.av-av_image-a2da42523847e50c79f99ab133ffce66 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-a2da42523847e50c79f99ab133ffce66 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-a2da42523847e50c79f99ab133ffce66 av-styling- avia-align-center  avia-builder-el-8  el_after_av_heading  el_before_av_textblock '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-4243 avia-img-lazy-loading-not-4243 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-1030x457.png\" alt='' title='Landing Page_Klinische Bewertung_3 (EN)'  height=\"457\" width=\"1030\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-1030x457.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-300x133.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-768x341.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-1536x682.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-1500x666.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-705x313.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN-450x200.png 450w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_3-EN.png 1673w\" sizes=\"(max-width: 1030px) 100vw, 1030px\" \/><\/div><\/div><\/div>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>The &#8220;Clinical Evaluation&#8221; module of the BAYOOSOFT Risk Manager offers a solution compliant with <strong>MDR<\/strong> and <strong>MEDDEV 2.7.1 rev4<\/strong> to support you in the same process. An intuitive user interface as well as the complete coverage of the process phases allow you to start immediately with the identification and verification of the relevant data.<\/p>\n<\/div><\/section>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_hr-fbebcb4fe7f7f93a621d8b6783460008\">\n#top .hr.hr-invisible.av-av_hr-fbebcb4fe7f7f93a621d8b6783460008{\nheight:30px;\n}\n<\/style>\n<div  class='hr av-av_hr-fbebcb4fe7f7f93a621d8b6783460008 hr-invisible  avia-builder-el-10  el_after_av_textblock  el_before_av_one_half '><span class='hr-inner '><span class=\"hr-inner-style\"><\/span><\/span><\/div>\n\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-15d750bd1b332b34c6e70b077ebbccdf\">\n.flex_column.av-av_one_half-15d750bd1b332b34c6e70b077ebbccdf{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-15d750bd1b332b34c6e70b077ebbccdf av_one_half  avia-builder-el-11  el_after_av_hr  el_before_av_one_half  first flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-23a6838b7a3efea789f9d00b701e2de8\">\n.avia-image-container.av-av_image-23a6838b7a3efea789f9d00b701e2de8 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-23a6838b7a3efea789f9d00b701e2de8 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-23a6838b7a3efea789f9d00b701e2de8 av-styling- av-hover-grow avia-align-center  avia-builder-el-12  el_before_av_textblock  avia-builder-el-first '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-4239 avia-img-lazy-loading-not-4239 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1.png\" alt='Clinical Evaluation Plan' title='Landing Page_Klinische Bewertung_1 (EN)'  height=\"743\" width=\"1668\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1.png 1668w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-300x134.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-1030x459.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-768x342.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-1536x684.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-1500x668.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-705x314.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_1-EN-1-450x200.png 450w\" sizes=\"(max-width: 1668px) 100vw, 1668px\" \/><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>In the &#8220;Clinical Evaluation Plan&#8221; section, you describe your product in text form, add images and plan the scope of the clinical evaluation taking into account the state of the art, claims and features. You can add references to existing studies and internal documents and evaluate the similarity of equivalent products.<\/p>\n<\/div><\/section><\/p><\/div>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8\">\n.flex_column.av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8{\nborder-radius:0px 0px 0px 0px;\npadding:0px 0px 0px 0px;\n}\n<\/style>\n<div  class='flex_column av-av_one_half-c8fc129dc35fd1ae2a1e410224d39ea8 av_one_half  avia-builder-el-14  el_after_av_one_half  avia-builder-el-last  flex_column_div av-zero-column-padding  '     ><p>\n<style type=\"text\/css\" data-created_by=\"avia_inline_auto\" id=\"style-css-av-av_image-36a0d36f543b12de72c83442f5838a14\">\n.avia-image-container.av-av_image-36a0d36f543b12de72c83442f5838a14 img.avia_image{\nbox-shadow:none;\n}\n.avia-image-container.av-av_image-36a0d36f543b12de72c83442f5838a14 .av-image-caption-overlay-center{\ncolor:#ffffff;\n}\n<\/style>\n<div  class='avia-image-container av-av_image-36a0d36f543b12de72c83442f5838a14 av-styling- av-hover-grow avia-align-center  avia-builder-el-15  el_before_av_textblock  avia-builder-el-first '   itemprop=\"image\" itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/ImageObject\" ><div class=\"avia-image-container-inner\"><div class=\"avia-image-overlay-wrap\"><img decoding=\"async\" fetchpriority=\"high\" class='wp-image-4241 avia-img-lazy-loading-not-4241 avia_image ' src=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN.png\" alt='' title='Landing Page_Klinische Bewertung_2 (EN)'  height=\"743\" width=\"1675\"  itemprop=\"thumbnailUrl\" srcset=\"https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN.png 1675w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-300x133.png 300w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-1030x457.png 1030w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-768x341.png 768w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-1536x681.png 1536w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-1500x665.png 1500w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-705x313.png 705w, https:\/\/www.riskmanager.net\/wp-content\/uploads\/sites\/5\/2020\/08\/Landing-Page_Klinische-Bewertung_2-EN-450x200.png 450w\" sizes=\"(max-width: 1675px) 100vw, 1675px\" \/><\/div><\/div><\/div><br \/>\n<section  class='av_textblock_section av-av_textblock-2de302bf1aa3cf4c9157dbe6f50ac7eb '   itemscope=\"itemscope\" itemtype=\"https:\/\/schema.org\/CreativeWork\" ><div class='avia_textblock'  itemprop=\"text\" ><p>Identify and evaluate clinical data relevant to the device and its intended use through a systematic scientific literature search. Appropriate search and selection criteria define the search. 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